BR112022022198A2 - INJECTABLE FORMULATION - Google Patents

INJECTABLE FORMULATION

Info

Publication number
BR112022022198A2
BR112022022198A2 BR112022022198A BR112022022198A BR112022022198A2 BR 112022022198 A2 BR112022022198 A2 BR 112022022198A2 BR 112022022198 A BR112022022198 A BR 112022022198A BR 112022022198 A BR112022022198 A BR 112022022198A BR 112022022198 A2 BR112022022198 A2 BR 112022022198A2
Authority
BR
Brazil
Prior art keywords
formulations
injectable formulation
salt
pharmaceutical formulations
dimethyltryptamine
Prior art date
Application number
BR112022022198A
Other languages
Portuguese (pt)
Other versions
BR112022022198B1 (en
Inventor
Claire Layzell Marie
Maxwell Rennie James
Original Assignee
Small Pharma Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB2013571.1A external-priority patent/GB202013571D0/en
Priority claimed from US17/006,115 external-priority patent/US20220062237A1/en
Application filed by Small Pharma Ltd filed Critical Small Pharma Ltd
Publication of BR112022022198A2 publication Critical patent/BR112022022198A2/en
Publication of BR112022022198B1 publication Critical patent/BR112022022198B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

FORMULAÇÃO INJETÁVEL. São fornecidas neste documento formulações farmacêuticas, métodos para sua produção e seus usos. As formulações farmacêuticas compreendem um sal de um composto de dimetiltriptamina opcionalmente substituído, um tampão, que é separado do sal e água. As formulações têm valores de pH de cerca de 3,5 a cerca de 6,5 e osmolalidades de cerca de 250 a cerca de 350 mOsm/Kg. Tais formulações são opcionalmente adequadas para injeção, sendo estáveis e clinicamente aceitáveis, e têm usos potenciais no tratamento de distúrbios psiquiátricos ou neurológicos.INJECTABLE FORMULATION. Pharmaceutical formulations, methods for their production and their uses are provided in this document. Pharmaceutical formulations comprise a salt of an optionally substituted dimethyltryptamine compound, a buffer, which is separated from the salt, and water. The formulations have pH values from about 3.5 to about 6.5 and osmolalities from about 250 to about 350 mOsm/Kg. Such formulations are optionally suitable for injection, are stable and clinically acceptable, and have potential uses in the treatment of psychiatric or neurological disorders.

BR112022022198-3A 2020-08-28 2021-08-20 INJECTABLE FORMULATION BR112022022198B1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
GBGB2013571.1A GB202013571D0 (en) 2020-08-28 2020-08-28 Injectable formulation
GB2013571.1 2020-08-28
US17/006,115 US20220062237A1 (en) 2020-08-28 2020-08-28 Injectable formulation
US17/006,115 2020-08-28
PCT/EP2021/073189 WO2022043227A1 (en) 2020-08-28 2021-08-20 Injectable formulation

Publications (2)

Publication Number Publication Date
BR112022022198A2 true BR112022022198A2 (en) 2023-03-14
BR112022022198B1 BR112022022198B1 (en) 2023-08-15

Family

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Also Published As

Publication number Publication date
KR102636385B1 (en) 2024-02-14
ZA202301086B (en) 2024-04-24
KR20220165819A (en) 2022-12-15
AU2021334933B2 (en) 2023-01-19
CA3179335A1 (en) 2022-03-03
IL298129A (en) 2023-01-01
CN115701994B (en) 2024-03-08
AU2021334933A1 (en) 2022-11-10
EP4138818A1 (en) 2023-03-01
WO2022043227A1 (en) 2022-03-03
MX2022014128A (en) 2023-02-14
JP7422474B2 (en) 2024-01-26
CN115701994A (en) 2023-02-14
JP2023533436A (en) 2023-08-03
CA3179335C (en) 2024-03-05

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Legal Events

Date Code Title Description
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 20/08/2021, OBSERVADAS AS CONDICOES LEGAIS

B25G Requested change of headquarter approved

Owner name: SMALL PHARMA LTD (GB)